Biomet® Cemented Cup Hip System XL-223654

GUDID 00887868343421

Biomet Orthopedics, LLC

Non-constrained polyethylene acetabular liner

• Primary Device ID: 00887868343421
• NIH Device Record Key: 219c2308-2d11-4576-aafd-f0883fc7b8f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biomet® Cemented Cup Hip System
• Version Model Number: XL-223654
• Catalog Number: XL-223654
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868343421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042051

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-26
• Device Publish Date: 2019-04-18

On-Brand Devices [Biomet® Cemented Cup Hip System]

• 00887868343483: XL-223666
• 00887868343476: XL-223664
• 00887868343469: XL-223662
• 00887868343452: XL-223660
• 00887868343445: XL-223658
• 00887868343438: XL-223656
• 00887868343421: XL-223654
• 00887868343414: XL-223652
• 00887868343407: XL-223250
• 00887868343391: XL-223248
• 00887868343384: XL-222846
• 00887868343377: XL-222844
• 00887868343360: XL-222642
• 00887868343353: XL-213666
• 00887868343346: XL-213664
• 00887868343339: XL-213662
• 00887868343322: XL-213660
• 00887868343315: XL-213658
• 00887868343308: XL-213656
• 00887868343292: XL-213654
• 00887868343285: XL-213652
• 00887868343278: XL-213250
• 00887868343261: XL-213248
• 00887868343254: XL-212846
• 00887868343247: XL-212844
• 00887868343230: XL-212642